Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy Compared to a Matched Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Passive range of motion
研究概览
简要总结
Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Selective dorsal rhizotomy (SDR) is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent further morbidities. Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The results of this study will have direct clinical impact by equipping providers with the necessary information to counsel families during medical decision making.
详细描述
Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Excessive spasticity is thought to be uncomfortable, reduce function, cause gait deviations (e.g. equinus), and contribute toward musculoskeletal deformity and an elevated energy cost while walking. As such, SDR is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent the aforementioned morbidities.
Treatment philosophies differ widely in regards to how aggressively to manage spasticity. Some centers (e.g. Gillette) aggressively treat spasticity early in life through a variety of measures such as SDR, intrathecal baclofen pumps, and botulinum toxin injections. Other centers (e.g. Shriners Hospitals for Children - Salt Lake City and Spokane) offer little in the way of spasticity reduction treatments.
There are several compelling reasons to conduct the proposed research study. First, emerging evidence suggests that the elimination of spasticity during childhood via SDR does not prevent contractures and only partially explains poor gross motor function, both previously thought to be clear outcomes of the surgery. Additionally, many of the longitudinal cohort studies that examined SDR outcomes have shown many outcome measures peak 1-3 years after surgery, and then decline toward baseline (i.e. pre-SDR) levels. Lastly, the quality of the SDR outcome literature is poor. Rarely are outcomes looked at in context of a proper control group. Either a control group is absent or comprised of typically developing children. This limits our ability to understand how patients with cerebral palsy may age without undergoing an SDR.
Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The surgery, in general, is costly to families (time, expense, risk, etc.) and clinicians should have every confidence in the intended outcomes for any intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Passive range of motion
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare passive range of motion, measured by lower extremity physical exam, across groups
Diener Satisfaction with Life Scale
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess satisfaction using the Diener Satisfaction with Life Scale (self-reported survey, 5 dissatisfied- 35 satisfied) and compare across groups
World Health Organization (WHO) Quality of Life Scale
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess satisfaction using the WHO Quality of Life Scale (self-reported survey, 0 low quality of life - 100 high quality of life) and compare across groups
Multiple Sclerosis Spasticity Scale (MSSS-88)
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess pain using portions of the MSSS-88 (self-reported survey, 21 not at all bothered - 84 extremely bothered) and compare across groups
Spasticity
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare spasticity, measured by Modified Ashworth Score (0 no increase in tone - 4 rigid in flexion or extension), across groups
Three-dimensional gait and motion analysis
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare three-dimensional gait kinematics and kinetics across groups
Energy expenditure
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare energy expenditure across groups
Selective motor control
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare selective motor control (0 patterned movement - 2 complete isolated movement) across groups
Lower extremity strength
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Compare lower extremity strength, measured by the manual muscle test, across groups
Gillette Functional Assessment Questionnaire (Gillette FAQ)
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess function and activity using the Gillette FAQ (self-reported survey, 0 low function - 10 high function) and compare across groups
Participation Enfranchisement survey
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess participation using the Participation Enfranchisement survey (self-reported survey, true/false) and compare across groups
Gross Motor Function Measure (GMFM-66)
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess function using portions of the GMFM-66 (0 low function - 100 high function) and compare across groups
Functional Mobility Scale (FMS)
时间窗: Time of long-term follow-up research visit (on average 10 years post-baseline)
Assess function and activity using the FMS (self-reported survey, 1 uses wheelchair - 6 independent) and compare across groups
次要结局
- Change in gait and motion analysis(Baseline (qualifying exam for cases and controls) compared to long-term follow-up research visit (on average 10 years post-baseline))
- Incidence of prior surgery and anti-spastic treatments(Time of long-term follow-up research visit (on average 10 years post-baseline))
- Cost of prior surgery and anti-spastic treatments(Time of long-term follow-up research visit (on average 10 years post-baseline))
研究者
Michael H Schwartz, PhD
Director of Bioengineering Research, Gillette Children's Specialty Healthcare; Associate Professor of Orthopaedic Surgery, University of Minnesota - Twin Cities
Gillette Children's Specialty Healthcare